Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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Minimizing Regulatory Risk For Biologics Manufacturing Changes

Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.

GUEST COLUMNISTS

Selecting The Right eQMS To Maximize Quality Maturity
Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.
How AI Could Clear Logistics Roadblocks Limiting Patient Access To CGT
Patient access often gets mischaracterized solely as a cost and pricing issue. A discussion among industry leaders reaches a deeper, more complex conclusion.
FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing
The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.
Validating Candel's BLA-Ready Analytics Profile
The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.
Mapping Candel Therapeutics' Sprint To The BLA Finish Line
Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.
The Hidden Operational Cost Contained In Every Small Molecule Portfolio
The volume of post-approval changes is rising and the manual approaches that have worked until now are no longer adequate. Get ahead of this to spend less and execute faster.
Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation
Scientific and regulatory leaders in the Asia-Pacific region met recently for an exchange of strategies to strengthen convergence and technical competence.
U.S. Pharma Tariffs And MFN Become Law After April 2 Update
Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.

PHARMA OUTSOURCING WHITE PAPERS

Designing, Selecting, And Developing Bioconjugates For Clinical Success
Accelerate the development of complex bioconjugates to unlock new possibilities for targeted therapies and advance the next generation of precision medicine.

A Risk-Based Approach To Plasmid DNA And mRNA Process Development
Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
Solve ATMP Aseptic Filling Challenges With Gloveless Isolators
Human intervention is the top contamination risk in ATMP manufacturing. Robotic gloveless isolators address that risk through full automation and real-time monitoring during aseptic filling.
Building the Next Generation of TIDES Manufacturing Excellence
Rising demand for complex TIDES therapies is shifting manufacturing expectations, driving adoption of continuous processing, digital tools, stronger supply strategies, and greener, scalable synthesis.
Revolutionizing Drug Discovery From "Undruggables" To AI
Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.
Accelerated Development Of Solid Oral Dosage Formulation For IND Submission
This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.